Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples

NCT03186534 | Completed Phase 2 DMC

• 1 other identifier: R01AA024065
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population. Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, participants were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple. The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or \~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment. The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. The investigators will conduct an RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program.

Conditions

Hiv; Chlamydia; Gonorrhea; Relation, Interpersonal

Outcome Measures

Primary Outcomes (4)

• Condomless anal sex

  change in number of condomless anal sex acts with serodiscordant or unknown status partners

  Baseline, 3-, 6-, 9-, 12-months

• Sexual Agreement Concordance

  change in concordance between each member of the dyad in the rules of their sexual agreement (monogamy or non-monogamy agreement)

  Baseline, 3-, 6-, 9-, 12-months

• Sexual Agreement Breaks

  occurrence of breaks in the rules of couples' sexual agreement (monogamy or non-monogamy agreement)

  Baseline, 3-, 6-, 9-, 12-months

• Occurrence of Sexually Transmitted Infections

  the incidence (number of new cases or diagnoses) of Chlamydia and Gonorrhea at 12 months

  Baseline, 12-months

Secondary Outcomes (2)

• HIV Testing

  Baseline, 3-, 6-, 9-, 12-months

• Antiretroviral Medication Adherence

  Baseline, 3-, 6-, 9-, 12-months

Other Outcomes (5)

• Pre-Exposure Prophylaxis

  Baseline, 3-, 6-, 9-, 12-months

• Pre-Exposure Prophylaxis Adherence

  Baseline, 3-, 6-, 9-, 12-months

• HIV Viral Load

  Baseline, 12-months

Study Arms (2)

2GETHER

EXPERIMENTAL

2GETHER is an HIV prevention and relationship education program designed for young male couples. 2GETHER consists of 4 sessions (2 group sessions, 2 individualized couple session) administered over the course of 1 month (1 session per week). Group sessions focus on developing skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.

Behavioral: 2GETHER

Positive Affect Enhancement

ACTIVE COMPARATOR

The control condition is a positive affect enhancement program for couples. This is an active and attention-matched control condition. Group sessions focus on developing various coping skills that aim to enhance positive emotions in couples, and individualized couple sessions focus on skills implementation.

Behavioral: Positive Affect Enhancement

Interventions

2GETHER BEHAVIORAL

Communication skills, coping skills, problem-solving, acceptance, HIV prevention

2GETHER

Positive Affect Enhancement BEHAVIORAL

coping skills for enhancing positive emotions, mindfulness

Positive Affect Enhancement

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: participants required to be assigned male at birth and currently identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both members of the couple assigned male at birth and currently identify as male
• Both members of the couples at least 18 years of age; at least one between the ages of 18-29 years
• Both members of the couple identify one another as primary partners
• Couple has had oral or anal sex with one another in the past 3 months
• At least one member of the couple reports condomless anal sex with a serodiscordant or unknown status partner during the past 3 months
• Both members of the couple read and speak English at 8th grade level or better
• Both members have Internet access
• Both members audio recording of intervention sessions

You may not qualify if:

• Severe intimate partner violence

Sponsors & Collaborators

• Northwestern University: lead
• University of Cincinnati: collaborator
• Howard Brown Health Center: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009 Jun 1;23(9):1153-62. doi: 10.1097/QAD.0b013e32832baa34.

  PMID: 19417579 BACKGROUND

• Greene GJ, Fisher KA, Kuper L, Andrews R, Mustanski B. "Is this normal? Is this not normal? There's no set example": Sexual Health Intervention Preferences of LGBT Youth in Romantic Relationships. Sex Res Social Policy. 2015 Mar;12(1):1-14. doi: 10.1007/s13178-014-0169-2.

  PMID: 25678895 BACKGROUND

• Jiwatram-Negron T, El-Bassel N. Systematic review of couple-based HIV intervention and prevention studies: advantages, gaps, and future directions. AIDS Behav. 2014 Oct;18(10):1864-87. doi: 10.1007/s10461-014-0827-7.

  PMID: 24980246 BACKGROUND

• Markman HJ, Rhoades GK. Relationship education research: current status and future directions. J Marital Fam Ther. 2012 Jan;38(1):169-200. doi: 10.1111/j.1752-0606.2011.00247.x.

  PMID: 22283386 BACKGROUND

• Newcomb ME, Macapagal KR, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention. AIDS Behav. 2017 Aug;21(8):2464-2478. doi: 10.1007/s10461-017-1674-0.

  PMID: 28083833 BACKGROUND

• Smith MS, Greenawalt I, Moskowitz JT, Addington EL, Mustanski B, Newcomb ME. Results of a positive affect intervention for male couples: Change over time and effects on mental health. J Consult Clin Psychol. 2025 Jul;93(7):511-525. doi: 10.1037/ccp0000963.

  PMID: 40587318 DERIVED

• Newcomb ME, Swann G, Addington EL, Macapagal K, Moskowitz JT, Sarno EL, Whitton SW, Mustanski B. Randomized controlled trial of a relationship education and HIV prevention program for young male couples: Biomedical and behavioral outcomes. Health Psychol. 2025 Mar;44(3):297-309. doi: 10.1037/hea0001448.

  PMID: 39992776 DERIVED

• Smith MS, Newcomb ME. Substance Use and Relationship Functioning Among Young Male Couples. Arch Sex Behav. 2023 Jul;52(5):2097-2110. doi: 10.1007/s10508-023-02627-1. Epub 2023 Jun 23.

  PMID: 37351709 DERIVED

• Newcomb ME, Sarno EL, Bettin E, Conway A, Carey J, Garcia C, Hill R, Jozsa K, Swann G, Addington EL, Ciolino JD, Macapagal K, Moskowitz JT, Mustanski B, Whitton SW. Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples. Trials. 2022 Jun 20;23(1):514. doi: 10.1186/s13063-022-06457-9.

  PMID: 35725624 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Chlamydia Infections; Gonorrhea

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections

Study Officials

• Michael E Newcomb, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jim Carey, MPH

  Northwestern University

  STUDY DIRECTOR

• Ricky Hill, Ph.D.

  Northwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: August 21, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)